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Sr. Associate/Manager, Regulatory Clin/non-Clin

Location United States, Remote

Workstyle Open to Hybrid
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Summary

This position supports Regulatory leadership in the development and execution of global nonclinical / clinical regulatory strategies through a program’s lifecycle.  This individual will lead the execution of delegated activities, including preparation for HA interactions and regulatory submissions in support of defined strategy.

Responsibilities

The responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which may include the following:

  • Support the development of the nonclinical / clinical regulatory strategy and plan.
  • Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.
  • Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with the Global RA Lead (GRL) and/or RA Nonclinical/Clinical (RNC) Lead.
  • Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
  • With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions.
  • Responsible for ensuring high quality nonclin/clinical content that adheres to regulations and guidances.
  • Lead the maintenance of IND/CTAs throughout the life of the studies
  • Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.
  • Collaborate with Reg PM to create and align submission timelines,
  • Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
  • Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.
  • Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s.
  • Oversee the archiving of HA submissions and correspondence
  • Support development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings.
  • Coordinate necessary interactions with RA International (INTL) in support of INTL MA filings. Examples include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs.
  • Attend relevant functional area and project team meetings.
  • Review, understand and stay up to date on regulations, guidelines relevant to responsibilities
  • Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary
  • Ensure that the PM timelines and tracker accurately reflect submission plans

Education & Experience

  • Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
  • 3- 4+ years experience with PhD; 5-6+ years with Masters or bachelor’s degrees
  • Nonclinical / Clinical Regulatory Affairs and rare disease experience preferred

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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